Celltrion's Vegzelma biosimilar approved for sale in United States
With the permission from the U.S. Food and Drug Administration (FDA), Celltrion has now obtained use approvals from the regions with the three largest markets, the United States, Japan and Europe.
The drug is an identical copy of bevacizumab, better known as Avastin, the name it is marketed under by Switzerland’s Roche. It is used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.
The global bevacizumab market was valued at $6.4 billion in 2021, with around $2.6 billion coming from the U.S. market. The U.S. has the largest bevacizumab market in the world.
Celltrion is still awaiting for use approval from Korea's Ministry of Food and Drug Safety. The results are expected to be released within the year, the company said.
Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they cost less.
BY SARAH CHEA [email@example.com]